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3.6 Standards Compliance
This device is designed to conform to the following standards:
• IEC 60601-1 General Requirements for Basic Safety and Essential Performance of Medical Electrical
Equipment
• EN 60601-1-2 Electromagnetic Compatibility
• ISO 80601-2-70 Sleep Apnea Breathing Therapy Equipment
• ISO 80601-2-74 Respiratory humidifying equipment
IEC 60601-1 Classification
• Degree of Protection Against Electric Shock: Type BF Applied Part
• Degree of Protection against Ingress of Water: Drip Proof, IPx2
• Mode of Operation: Continuous
Electrical
• Power Consumption 3.3 Vdc, max. 5A.
3.7 Warranty
The Sunset Heated CPAP Tube warranty is 30 days under normal operating
conditions. This is based on daily usage of 8 hours.
3.5 Product Specifications
Description
Specification
Sunset Heated CPAP Tube Length 6ft (1.83m)
Internal Diameter
19mm
Flow resistance @60 l min-1
≤ 0.1 kPa
Tubing Compliance Standards
ISO 5367:2000
ISO 8185:2007
ISO 80601-2-70:2015
ISO 80601-2-74:2017
Water resistance
IP22
Compatible
CPAP Machine Humidifiers
• Philips Respironics DreamStation
• Philips Respironics System One
Periodic visual safety inspections
that should be performed by the
OPERATOR
Daily
HUMIDIFIER classification
according to the ISO 80601-2-74 Humidifier classification: 2
